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Biosimilars Basics for Patients | FDA What is a biosimilar medication? A biosimilar is a biologic medication It is highly similar to a biologic medication already approved by FDA – the original biologic (also called the
What are biosimilar drugs and how do they compare to biologics? A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency The most recent biosimilar approval was Starjemza (ustekinumab-hmny), an interchangeable biosimilar to Stelara, on May 22, 2025
20 Common Biosimilar Drugs in the U. S. - GoodRx Biosimilar drugs are a growing subset of biologics being developed as a way to access the medications you need at a lower cost Biosimilar medications are highly similar in structure, safety, and effectiveness to an original (reference) biologic medication
Biosimilar medicines: Overview - European Medicines Agency (EMA) Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the European Union (EU)
Biosimilars 101 | SmithRx Learn how biosimilars provide lower-cost alternatives to expensive biologic drugs, improving access to life-saving treatments, reducing healthcare costs, and encouraging innovation
What are biosimilars? | Biosimilar Basics | Biosimilars Council Biosimilars are biologic medicines that are highly similar to a previously approved reference biologic currently on the market But what does that short definition of a biosimilar actually mean? Approved biosimilars on the market are safe, effective and are more competitively priced alternatives to brand name biologic medicines
What is biosimilar? A biosimilar is a recombinant protein which is engineered to be highly similar to a reference protein with regard to its biochemical fingerprint The biosimilar and reference product have no clinically meaningful differences in their critical quality attributes (CQAs) 3
Understanding Biosimilars: A Balanced Analysis - Center Forward Biosimilars are biologic medicines that have no clinically meaningful differences to an existing FDA-approved reference product’s clinical efficacy and safety profile Outside of Humira, and a couple of other self-administered drugs like insulin, the majority of biosimilars are for physician administered drugs